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Ortho Clinical Diagnostics Inc

Ortho Clinical Diagnostics Inc Recalls

All product recalls associated with Ortho Clinical Diagnostics Inc.

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Recall Summary

Total Recalls

970

Past Year

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 441–460 of 970 recalls

Ortho Clinical Diagnostics Inc: VITROS Chemistry Products Calibrator Kit 2- IVD calibrat...

Potential for Negatively Biased Na+ Urine Results Using Several Lots of VITROS Chemistry Products Calibrator Kit 2

FDADec 16, 2019Nationwide• Ortho Clinical Diagnostics Inc

Siemens Healthcare Diagnostics, Inc.: ADVIA Chemistry CardioPhase High Sensitivity C-Reactive P...

Atellica and ADVIA hsCRP calibrator accuracy has drifted away from the reference materials (ERM-DA470/IFCC), which is causing a high bias on QC and patient sample recovery.

FDANov 19, 2019Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica CH High Sensitivity C-Reactive Protein (HsCRP) C...

Atellica CH: The Atellica CH High Sensitivity CReactive Protein Calibrator (hsCRP CAL) is for in vitro diagnostic use in calibrating the hsCRP assay using the Atellica CH Analyzer.

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FDANov 19, 2019Nationwide• Siemens Healthcare Diagnostics, Inc.

Diagnostica Stago, Inc.: STA UNICALIBRATOR (ref. 00675)

A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observed on several External Quality Assessment (EQA) results.

FDANov 18, 2019AL, AK, AZ +39 more• Diagnostica Stago, Inc.

Diagnostica Stago, Inc.: STA SYSTEM CONROL N + P (ref. 00678)

FDANov 18, 2019AL, AK, AZ +39 more• Diagnostica Stago, Inc.

Hardy Diagnostics: HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and d...

False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited.

FDANov 14, 2019AZ, CA, IN +11 more• Hardy Diagnostics

Avanos Medical, Inc.: Haylard Closed Suction System for Neonates/Pediatrics, 5 ...

Avanos Medical has received reports stating that the central lumen of some 5 Fr Neonate/Pediatric Closed Suction Catheters may be fully blocked or partially blocked. This may cause the closed suction catheters (CSCs) to inadequately suction secretions and/or saline fluids form the patient's airway to prevent oxygen desaturation.

FDANov 5, 2019Nationwide• Avanos Medical, Inc.

Roche Diagnostics Operations, Inc.: Elecsys Anti-HAV IgM assay-for the in vitro qualitative d...

Current software version of the Anti-HAV IgM APP-file (version 06.05-101) downloaded an erroneous Border Area setting, (1.0 1.00) instead of (0.90 1.10).

FDAOct 28, 2019Nationwide• Roche Diagnostics Operations, Inc.

Ortho Clinical Diagnostics Inc: 7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Pr...

Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine Electrolyte Diluent (UED) (Product Code 1110352) when stored in a 2mL cup for 7 days

FDAOct 14, 2019Nationwide• Ortho Clinical Diagnostics Inc

Ortho Clinical Diagnostics Inc: Urine Electrolyte Diluent, Product Code: 1112352 - Produc...

Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine Electrolyte Diluent (UED) (Product Code 1110352) when stored in a 2mL cup for 7 days.

FDAOct 14, 2019Nationwide• Ortho Clinical Diagnostics Inc

Siemens Healthcare Diagnostics, Inc.: Atellica CH 930 Analyzer, Siemens Material Number 1106700...

On the Atellica CH 930 Analyzer, when scanning barcodes at the module console for Integrated Multisensor Technology (IMT) system fluids (Standard A (Std A) and Standard B (Std B)) for Sodium (Na), Potassium (K), and Chloride (Cl), the system will translate the decimal point separators to commas. This will result in invalid concentration values for the fluids, therefore the system will utilize default nominal values instead of lot specific IMT fluid concentration values for calculation of the calibrations and results for the Na, K, and Cl methods.

FDAOct 11, 2019Nationwide• Siemens Healthcare Diagnostics, Inc.

Roche Diagnostics Operations, Inc.: Cobas infinity central lab / cobas infinity core license-...

Cobasinfinity laboratory solution Version 2.4.1 through Version 2.5.4 Using a CommServer Driver - Incorrect Alarm Mapping

FDAOct 8, 2019Nationwide• Roche Diagnostics Operations, Inc.

Avanos Medical, Inc.: CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, La...

The connector piece to the PEG tube does not pass over the guidewire.

FDAOct 8, 2019CT, IN, MD +3 more• Avanos Medical, Inc.

Roche Diagnostics Operations, Inc.: Roche Homocysteine-In vitro test for the quantitative det...

Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules

FDAOct 4, 2019Nationwide• Roche Diagnostics Operations, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica CH 930 Analyzer

Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher.

FDASep 23, 2019AL, AZ, AR +33 more• Siemens Healthcare Diagnostics, Inc.

Axis-Shield Diagnostics, Ltd. 17 Luna Place Dundee United Kingdom: Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGEN...

There is a potential performance issue as detected by an under-recovery of sample results during routine testing.

FDASep 16, 2019Nationwide• Axis-Shield Diagnostics, Ltd. 17 Luna Place Dundee United Kingdom

Roche Diagnostics Operations, Inc.: Cobas c Bilirubin Total Gen.3 Catalog Number: 0579541919...

Due to low Quality Control recovery and invalid Calibration.

FDASep 11, 2019Nationwide• Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc.: Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Nu...

Due to low Quality Control recovery and invalid Calibration.

FDASep 11, 2019Nationwide• Roche Diagnostics Operations, Inc.

Ortho-Clinical Diagnostics: VITROS chemistry Products Cl- Slides, Catalog No. 6844471...

Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.

FDASep 10, 2019Nationwide• Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics: VITROS chemistry Products K+ Slides, Catalog No. 8157596....

Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.

FDASep 10, 2019Nationwide• Ortho-Clinical Diagnostics